Director, Pathogen Safety
NC-RTP, US
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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
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Summary:
Responsible for directing the Pathogen Safety department that provides support across the company for all aspects related to Viral Safety, TSE, and Pathoegn Safety Support and Compliance. This department is critical for generating data and scientific assessments to support the safety profile of Grifols products. Pathogen Safety support encompass the entire product development and production life cycle including investigational medicinal products, commercial manufacturing support, and post-production support. The incumbent is responsible for directing a staff of exempt scientists conducting applied research, development, and regulated validation studies aimed at inactivation and removal of potential pathogens during manufacture of plasma derived and recombinant products. He/She will be familiar with emerging and existing technologies capable of inactivation/removal of a broad spectrum of viruses. Incumbent is responsible for supporting regulatory filings, quality and regulatory audits, and other inquiries related to the pathogen safety of investigational or marketed products. The incumbent is responsible for understanding current regulatory expectations reqarding the pathogen safety of recombinant and plasma derived biotherapeutics and guiding viral validation and safety studies in support of clinical investigations and product registrations. This role will be a global scientific expert within the company for pathogen safety related issues. The incumbent will work with senior management, industry representatives, and regulators to establish policies and procedures related to Pathogen Safety of Grifols products.
Primary Responsibilities:
- Provide leadership for and coordinate the activities within the Pathogen Safety department.
- Provide leadership for and coordinate the activities within the Pathogen Safety department.
- Assure that project priorities and resources are aligned between the sections and that the goals of each section are achieved. Establish and manage the budget for the Pathogen Safety department.
- Serves as the global expert on pathogen safety issues. Direct the efforts to develop and implement appropriate viral safety methods for new and existing products that are compatible with plasma derived and biotechnology product integrity
- Direct the validation of viral reduction steps in support of investigational and marketed products. Assure that data generation and documentation meet regulatory requirements.
- Manage resources to ensure a continual improvement program is established and met.
- Assure that Grifols' pathogen safety policies and activities are consistent with regulatory and business requirements and establish Grifols as a leader in pathogen safety. Assure that the appropriate viral containment policies and requirements are satisfied.
- Recruit, train, develop and manage the staff to accomplish pathogen safety goals.
- Establish budgets and monitor expenditures.
Knowledge, Skills, and Abilities:
- Experience in project management, especially in the areas of plasma or biotechnology products
- Proven ability to take strong leadership role in organizational issues
- Experience in managing strategic and operational aspects of relationships with internal and external partners.
- Ability to make appropriate judgments on safety policy and compliance
- Team player with excellent communication skills. Able to effectively communicate sensitive issues both inside and outside the organization.
Education:
Advanced scientific degree, Ph.D. or M.D.
Experience:
10+ years experience in Pharmaceuticals and biotechnology with experience in one or more of the following areas: quality assurance, biological processing, virology, biochemistry, and biotechnology development. Background in virology, TSE and viral clearance study design desired.
Occupational Demands:
Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Frequently walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations and frequently travels within the United States. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others, relates sensitive information to diverse groups. Ability to apply abstract principles to solve complex conceptual issues. Performs a wide range of complex tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence.
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants in a manner consistent with the requirements of applicable state and local laws.
Location: NORTH AMERICA : USA : NC-RTP:USNC0003 - RTP NC-Research Building 85